IMMUNOCORP COATED TUBE IRMA HCG— 510(k) K910349

Substantially Equivalent

Immunocorp

FDA 510(k) clearance K910349 for IMMUNOCORP COATED TUBE IRMA HCG, Substantially Equivalent on 1991-03-21. Applicant: Immunocorp.

Clearance details

Applicant: Immunocorp
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1991-01-29
Decision date: 1991-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quebec, Canada, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code JHI

product code JHI

Malfunction: 1,055
Total: 1,055

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.